Study of the Use of Methoxyflurane Vs Placebo in the Management of Pain in Oral and Dental Emergencies in Adults: METODO (METhoxyflurane in ODOntology)

Regional University Hospital Center (CHRU)

Status and phase

Enrolling

Phase 3

Conditions

Dental Pain and Sensation Disorder

Treatments

Drug: control group (standard of care + placebo).

Drug: Experimenta group (standard of care + Methoxyflurane).

Study type

Interventional

Funder types

Other

Identifiers

NCT06495372

29BRC23.0024 (METODO)

Details and patient eligibility

About

With a chronic shortage of dentists in some regions, and an increase in life expectancy and living conditions, the number of patients admitted to oral health emergencies is on the rise. Pain is the main reason for consultation, and is particularly exacerbated in the orofacial sphere. Dental pain has several etiologies: infectious, inflammatory or traumatic accidents.Beyond the ethical aspects of acute pain management, pain relief is a real objective. Despite prioritization systems, patients can wait a long time in an unsettled environment, with tired and sometimes aggressive patients. Numerous recommendations exist to improve analgesia in emergency departments, but there are still difficulties in effectively and rapidly managing acute dental and orofacial pain. To meet this demand and facilitate the treatment process, an alternative solution using methoxyflurane (Penthrox®) could be considered. This product, mainly intended for emergency services, has been approved in Europe since 2016 for the "emergency relief of moderate to severe pain associated with trauma in conscious adult patients". Thus, it would be interesting to assess the value of methoxyflurane (Penthrox®) in the management of pain in oral emergencies as a wait-and-see solution.

Enrollment

192 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult patient (> 18 years)
Conscious patient consulting an oral emergency department with pain assessed as moderate to severe NRS greater than or equal to 4
Patient has social security affiliation or who beneficiary of such social security
Patients who have given informed consent

Exclusion criteria

Patients with a history of allergy to methoxyflurane or any of the components of Penthrox (take into account family history of severe allergic reactions)
Patients with a history of malignant hyperthermia (known or genetic predisposition)
Patients with hepatic impairment after use of methoxyflurane or halogenated hydrocarbon anesthesia
Patients with severe renal Failure
Patients with altered level of consciousness, whatever the cause: head trauma, drug or alcohol abuse
Patients with cardiovascular instability or respiratory depression
Pregnant or breast-feeding patients. Therefore, a urine pregnancy test will be performed for all patients of childbearing age eligible to participate in the study
Patients under legal protection (guardianship and curatorship) or deprived of liberty
Patients unable to speak or read French fluently, unable to understand the principle of a numerical scale, anxiety and satisfaction questionnaires, and unable to cooperate with tests